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Taking people in CanadaPhase 3

Tests rilvegostomig with chemotherapy and trastuzumab deruxtecan in HER2-positive stomach cancer

Tests rilvegostomig with chemotherapy and trastuzumab deruxtecan in people with HER2-positive stomach cancer.

Key facts

Who runs it
AstraZeneca
Where
Barrie, Brampton, Calgary, Chicoutimi, Edmonton, Hamilton, Lévis, Montreal, Toronto, and Winnipeg, CanadaSee the 10 sitesAlso in 27 other countries, 252 sites
Registry title
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
Status
Recruiting
Phase
Phase 3
People taking part
840 people, planned
Started
1 Mar 2025
Expected to end
9 Dec 2030
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rilvegostomig
  • Trastuzumab deruxtecan
  • Trastuzumab
  • Pembrolizumab
  • 5-fluorouracil
  • Capecitabine
  • Cisplatin
  • Oxaliplatin
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with HER2-positive stomach or gastroesophageal junction cancer that has spread or cannot be removed by surgery, and that has not been treated before. The tumor must have a PD-L1 CPS of 1 or more.

Age
18 years or older
Sex
Men and women
Disease stage
Locally advanced (cannot be removed by surgery) or metastatic gastric or gastroesophageal junction adenocarcinoma, with disease that can be measured by RECIST v1.1
Earlier treatment
No earlier treatment for this advanced or metastatic cancer. Enough time must have passed since any earlier treatment.
Biomarker or test result
HER2-positive tumor on biopsy; PD-L1 combined positive score (CPS) 1 or more; a recent tumor tissue sample for HER2 and PD-L1 testing

Main reasons for not taking part

  • Brain metastases or spinal cord compression, unless symptom-free, treated and stable
  • History of ILD or pneumonitis (lung inflammation)
  • Autoimmune or inflammatory disease needing long-term steroids or immune-suppressing treatment
  • Uncontrolled infection, or chronic or active hepatitis B or C infection unless controlled
  • Known dihydropyrimidine dehydrogenase enzyme deficiency

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • HER2 positive for gastric cancer on a tumor biopsy
  • PD-L1 combined positive score (CPS) ≥ 1
  • Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing
  • Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma
  • WHO or Eastern Cooperative Oncology Group performance status of 0 or 1
  • Have measurable target disease assessed by the Investigator based on RECIST v1.1
  • Have adequate organ and bone marrow function
  • LVEF ≥ 50% within 28 days before randomization
  • Adequate treatment washout period before randomization

Who cannot take part

  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence
  • Persistent toxicities caused by previous anti-cancer therapy
  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy
  • Recent receipt of live, attenuated vaccine
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
  • A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART)
  • Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors
  • Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study
  • Current or prior use of immunosuppressive medication within 14 days before study intervention
  • Uncontrolled infection including tuberculosis and active hepatitis A infection
  • Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals
  • Chronic/active HBV or HCV infection unless controlled
  • Clinically significant cardiac or psychological conditions
  • History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant illnesses
  • Any active non-infectious skin disease requiring systemic treatment
  • History of any of the following: drug-induced severe cutaneous adverse reaction
  • Lack of physiological integrity of the upper gastrointestinal tract
  • Known dihydropyrimidine dehydrogenase enzyme deficiency
  • Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Have you had medicine for the cancer (such as chemotherapy) since it was found that it cannot be removed by surgery or has spread?
  • Has your doctor told you that the cancer cannot be removed by surgery, or that it has spread to other parts of the body?
  • Has a test of your tumour shown that it is HER2-positive?
  • Have you ever had inflammation or scarring of the lungs, such as pneumonitis or interstitial lung disease?

Where in Canada

Also in 27 other countries, 252 sites

  • Barrie, OntarioHospital not named in the registryTaking people
  • Brampton, OntarioHospital not named in the registryNot yet recruiting
  • Calgary, AlbertaHospital not named in the registryTaking people
  • ChicoutimiHospital not named in the registryTaking people
  • Edmonton, AlbertaHospital not named in the registryTaking people
  • Hamilton, OntarioHospital not named in the registryNo longer taking part
  • Lévis, QuebecHospital not named in the registryNot yet recruiting
  • Montreal, QuebecHospital not named in the registryTaking people
  • Toronto, OntarioHospital not named in the registryTaking people
  • Winnipeg, ManitobaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

The 3 groups in the trial

  • Arm ATreatment being tested

    T-DXd + Rilvegostomig + Fluoropyrimidine (Capecitabine OR 5-FU)

    Treatment: Rilvegostomig, Trastuzumab deruxtecan, 5-fluorouracil, and Capecitabine

  • Arm BExisting treatment, for comparison

    Pembrolizumab + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)

    Treatment: Trastuzumab, Pembrolizumab, 5-fluorouracil, Capecitabine, Cisplatin, and Oxaliplatin

  • Arm CExisting treatment, for comparison

    Rilvegostomig + Trastuzumab + FP (5-FU plus cisplatin) or CAPOX (capecitabine plus oxaliplatin)

    Treatment: Rilvegostomig, Trastuzumab, 5-fluorouracil, Capecitabine, Cisplatin, and Oxaliplatin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)
Plain-language title
Tests rilvegostomig with chemotherapy and trastuzumab deruxtecan in HER2-positive stomach cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06764875, who can take part
Record updated
16 October 2026
Under construction, not live – A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer (NCT06764875) – Frontlight Research